Progesterone
DRUG FACTS:
0de91238-dacc-4a5c-86d8-ad94024b2c95
HUMAN OTC DRUG LABEL
May 20, 2025
BioActive Nutritional, Inc.
DUNS: 624980496
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Progesterone
PRODUCT DETAILS
INGREDIENTS (3)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL DISPLAY:
BIOActiveNutritional
PROGESTERONE
HOMEOPATHIC
1 fl. oz. (30mL)
INDICATIONS & USAGE SECTION
USES:
For temporary relief of aching legs, backache, mood swings, painful menses, painful breasts, headaches, hot flashes, and nervousness.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:
Progesterone 6X, 12X, 30X, 12C, 30C.
OTC - PURPOSE SECTION
PURPOSE:
Progesterone - hormonal support**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
WARNINGS SECTION
WARNINGS:
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in a cool, dry place.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN:
In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS:
• 10 drops orally, 3 times a day.
• Consult a health care professional for use in children under 12 years of age.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS:
Demineralized Water, 25% Ethanol
OTC - QUESTIONS SECTION
QUESTIONS:
Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com
1-800-288-9525